Osteomyelitis - Foot Clinical Trial
Official title:
A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot
The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers. Participants will randomized into two groups: - Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice. - Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.
Patient with a diagnosis of ostemileytis localised in the forefoot will be randomized into two groups. - Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice. - Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible. In any case a primary intent closure is pursued, both in Group A and B, a vacuum percutaneous drainage would be placed before closing the wound and removed in 2nd post-operative day, if necessary, by the surgeon. Systemic antibiotic therapy will be started immediately on empirical basis, as per normal practice. After the removal of drainage, or after the first post-operative control in 2nd post-operative day, as done routinely at study sites, patients will be evaluated biweekly either if they are still admitted or if they were dismissed and will be followed up by investigators blinded toward the groups. At each visit local conditions and eventual dressing changes will be recorded, alongside with any possible complication, like non-healing, re-infection, and any systemic and local adverse event. Patients will be followed every second week up to 3 months or until complete healing and then at six months and 12 months from surgical interventions. At six-month and 12 -month follow-up, rate of healing and recurrences will be checked; x-rays will be performed at pre-operation visit, immediate post and at 12 months Follow Up visit. Histopathological samples collected as per normal practice during the surgery will be analyzed with standard protocol in local laboratories. Healing will be defined as complete re-epithelization of the lesion, without secretion or drainage, confirmed at two successive follow-up visits. For the sake of calculating healing time, healing will be attributed to the first visit. At each visits a local and systemic evaluation of the wound will be done as per normal practice. A photo of the wound will be taken at visits: Pre-operative , Immediate post-op, 6 weeks post-op, 6 months and 12 months after the surgical procedure. Laboratory exams will be performed as per hospital standard of care. At pre-operative and 6 months and 12 months visits patients compile Quality of Life and Foot Function Index Questionnaires. ;